Ketoconazole cream Clinical particulars

4.1 Therapeutic indications

For topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea
cruris, tinea manus and tinea pedis infections due to Trichophyton spp, Microsporon spp and Epidermophyton
spp. Ketoconazole2% cream is also indicated for the treatment of cutaneous candidosis (including vulvitis),
tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum)
spp.
4.2 Posology and method of administration
Ketoconazole cream is for use in adults.
Tinea pedis:
Ketoconazole2% cream should be applied to the affected areas twice daily. The usual duration of treatment for
mild infections is 1 week. For more severe or extensive infections (eg involving the sole or sides of the feet)
treatment should be continued until a few days after all signs and symptoms have disappeared in order to
prevent relapse.
For other infections:
Ketoconazole2% cream should be applied to the affected areas once or twice daily, depending on the severity
of the infection.
The treatment should be continued until a few days after the disappearance of all signs and symptoms. The
usual duration of treatment is: tinea versicolor 2–3 weeks, tinea corporis 3–4 weeks.
The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures in
regard to hygiene should be observed to control sources of infection or reinfection.
Seborrhoeic dermatitis is a chronic condition and relapse is highly likely.
Method of administration: Cutaneous administration.
Paediatrics
There are limited data on the use of ketoconazole 2% cream in paediatric patients.

Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antifungals for Topical Use,Imidazole and triazole derivatives
ATC Code: D01AC08
Usually ketoconazole cream acts rapidly on pruritus, which is commonly seen in dermatophyte and yeast infections, as well as skin
conditions associated with the presence of Malassezia spp. This symptomatic improvement is observed before the first signs of healing are
observed.
Ketoconazole, a synthetic imidazole dioxolane derivative, has a potent antimycotic activity against dermatophytes such as Trichophyton
spp., Epidermophyton floccosum and Microsporum spp. and against yeasts, including Malassezia spp. and Candida spp. The effect on
Malassezia spp. is particularly pronounced.
A study in 250 patients has shown that application twice daily for 7 days of ketoconazole 2% cream vs clotrimazole 1% cream for 4 weeks on
both feet demonstrated efficacy in patients with tinea pedis (athlete's foot) presenting lesions between the toes. The primary efficacy
endpoint was negative microscopic KOH examination at 4 weeks. Ketoconazole 2% treatment showed equivalent efficacy to 4 weeks
clotrimazole 1% treatment. There was no evidence of relapse following treatment with ketoconazole cream at 8 weeks.
5.2 Pharmacokinetic properties
Plasma concentrations of ketoconazole were not detectable after topical administration of Ketoconazole2% Cream in adults on the skin. In
one study in infants with seborrhoeic dermatitis (n = 19), where approximately 40 g of Ketoconazole2% cream was applied daily on 40% of
the body surface area, plasma levels of ketoconazole were detected in 5 infants, ranging from 32 to 133 ng/mL.
5.3 Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating
little relevance to clinical use.

Therapeutic indications Beclometasone dipropionate Cream is indicated for the treatment of the various
forms of eczema in children and adults including atopic and discoid eczemas; primary irritant and allergic
dermatitis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses including lichen simplex;
intertrigo; discoid lupus erythematosus. The cream is often appropriate for moist or weeping surfaces
and the ointment for dry, lichenified or scaly lesions but this is not invariably so. 4.2 Posology and
method of administration Route of Administration: Topical Dosage and Administration Beclometasone
dipropionate Cream should be applied thinly over the whole of the affected area and gently rubbed in.
Initially, application should be made twice daily, but when improvement is seen, the intervals between
applications may be extended and treatment eventually stopped. If no improvement is seen within two
to four weeks, reassessment of the diagnosis, or referral may be necessary. After cessation of
treatment, should the condition recur, twice daily treatment should be re-instituted. However, when
improvement is seen again, the intervals between applications may be gradually extended until
maintenance dosing of application every third or fourth day is achieved. This is likely to avoid
subsequent reappearance of the condition. The beneficial effects may be enhanced by preliminary use
of hot soaks, or by intermittent applications or occlusive dressings

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties Beclometasone dipropionate is an active corticosteroid with topical anti-

inflammatory activity. 5.2 Pharmacokinetic properties The extent of percutaneous absorption of topical
corticosteroid is determined by many factors including the vehicle, the integrity of the epidermal
barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact
skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once
absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways
similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in
varying degrees. Corticosteroids are metabolised primarily by the liver and are then excreted by the
kidneys. 5.3 Preclinical safety data There are no preclinical data of relevance to the prescriber which are
additional to that in other sections of the SmPC.